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Streamlined GMP Requirements for Combo Products

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Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for com...

Guidance for Computer Software Assurance for Devices

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FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency say...

FDA Approves BMS Plaque Psoriasis Drug

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FDA approves a Bristol Myers Squibb NDA for plaque psoriasis drug Sotyktu (deucravacitinib), a first-in-class, oral, selective, al...

Biomarin Reports Leukemia in Patient on Gene Therapy

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BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene...

FDA Taps PATHs Kaslow as Vaccine Chief

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FDA selects non-profit PATHs chief scientific officer David Kaslow as CBER Office of Vaccines Research and Review director.

Statement of Identity and Strength Labeling Draft Guide

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Federal Register notice: FDA makes available a draft guidance entitled Statement of Identity and Strength Content and Format of L...

Teva Rebuts GSK Argument in Skinny Label Case

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Teva urges the U.S. Supreme Court to dismiss a GlaxoSmithKline argument that the high court should not hear Tevas appeal of a skin...

Boston Imaging V7 Ultrasound Cleared

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FDA clears a Boston Imaging 510(k) for its V7, an ultrasound system said to enhance image clarity.

FDA Approves Spectrum Pharmas Rolvedon

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FDA approves Spectrum Pharmaceuticals Rolvedon (eflapegrastim-xnst) injection for decreasing febrile neutropenia-associated infect...

FDA Revokes 2 EUAs for Covid Tests

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Federal Register notice: FDA revokes two emergency use authorizations one issued to Becton Dickinson and the other to Talis Biome...